Develop PK and Immunogenicity immunoassay test methods with minimal or no supervision. Validate immunoassay test methods and analyze bioanalytical samples per SOPs and test methods and report results to bioanalytical Principal Investigator.
- Work hands-on to develop and validate PK, Immunogenicity and Neutralizing antibody immunoassays (ELISA, MSD, etc.) and cell-based assays.
- Provide scientific expertise and oversight in assay development, validation and sample analysis.
- Troubleshoot problems and advise lab team, as needed.
- Oversee laboratory equipment use and maintenance.
- Review developmental, validation and sample data.
- Develop and write bioanalytical test methods as necessary.
- Operate laboratory equipment and perform routine maintenance as required.
- Prepare laboratory solutions, reagents, and bio-conjugated materials following standardized procedures.
- Accurately pipet and quantitatively transfer solutions and samples.
- Carefully follow laboratory instructions, procedures and methods.
- Conduct lab operations according to applicable SOPs, test methods and regulatory requirements.
- Follow good documentation practices; keep lab records in a consistent, compliant and accurate manner. Record documentation per appropriate formats (e.g. controlled form, notebook, logbook)
- Ensure routine maintenance, scheduled performance verification testing, documentation and training for assigned equipment is conducted as required per applicable SOPs.
- Assist with mentoring/training less experienced staff.
- At least 3-5 years’ hands-on experience (CRO or Pharmaceutical) in large molecule immunoassay development/validation.
- Experience as a Medical Technologist will be considered in lieu of pharmaceutical experience
- Knowledge of applicable GLP and GCP regulations and bioanalytical guidelines
- Must be able to multi-task in a dynamic working environment.
- Good verbal and written communications skills a must-have.
If interested, please send CV to Info@bds.com.